From idea to production, the development of a new drug can take up to 10 years and cost about $800 million. But many risks abound in the development process that can cause complete failure. The process usually starts with the idea that an existing chemical substance has therapeutic value or that the structure of an existing drug can be modified for new clinical uses. Out of 10,000 chemicals tested in a laboratory, only one may eventually become a drug. Besides the expense necessary to produce them, drugs are heavily regulated by the bureaucracy of government agencies. In the United States, the FDA not only approves new drugs, but also determines how drugs are produced and sold by continually monitoring the development and use of all drugs sold. This is the backdrop against which a pharmaceutical company (“pharma 102”) markets its precious few developed drugs 104. See FIG. 1.
Traditionally, a sales representative 106 of the pharma 102 visits one or more prescribers 110, leaves behind some drug samples of the drugs 104, and waits in trust that the prescribers 110 will prescribe these drug samples to their patients. When a sales representative 106 visits a prescriber, such as one of the prescribers 110, the sales representative 106 is performing two actions together called a drug detail. First, the sales representative 106 educates the prescriber about the efficacy of the drug samples for various disease states and differentiates them from any competitive drugs in the marketplace. Second, the sales representative 106 leaves drug samples behind with the prescriber so that he can dispense these drug samples to his patients.
A triangle 108 hierarchically organizes all prescribers into deciles, which are numbers that divide a frequency distribution (the regularity of which a prescriber prescribes drugs) into 10 classes such that each contains the same number of prescribers. The upper 1-3 deciles describe one or more prescribers 110. The remaining 4-10 deciles describe one or more prescribers 112. Prescribers at deciles 1-3 comprise 25 percent of all prescribers and generate 50 percent of all prescriptions. The remaining 75 percent of prescribers are at deciles 4-10 and prescribe the remaining 50 percent of all other prescriptions. Because individual prescribers at deciles 4-10 do not generate as much income for the pharma 102 compared to those in the top three deciles, the sales representative 106 typically does not visit these prescribers, but instead, focuses her efforts on prescribers 110 at deciles 1-3.
The reason for this is mainly economic. For each sales representative 106, the pharma 102 incurs numerous expenses including purchasing and maintaining an automobile for the sales representative 106 to travel to the prescribers, and paying a salary, benefits, and so on. Also a growing number of billions of dollars are spent each year on everything necessary to support the distribution of drug samples, such as packaging and delivery. When this cost is multiplied by the cost of employing multiple sales representatives, the pharma 102 cannot afford to visit all prescribers to solicit patronage of its drugs.
But there are still other reasons beyond the economic ones that prevent the sales representative 106 from visiting all prescribers. One or more prescribers 112 may be located in remote areas making it difficult for the sales representative 106 to reach them. Certain prescribers 112 do not wish to see a sales representative 106 because they are too busy with their practice or they belong to an organization, such as a hospital, that forbids sales representatives from soliciting prescribers on its premises. Another reason why most prescribers 112 are not visited by the sales representative 106 has to do with absences by the sales representative 106 because of parental leaves, military duties, firings, layoffs, or unexpected resignations, and so on.
While it is cost prohibitive for the pharma 102 to send sales representatives to visit all prescribers, prescribers who know about the drug samples and want access to drug samples have problems too. If the prescriber were to be interested in designing a therapy from five different brands of drugs, he might have to track down five different sales representatives to get the drug samples. The prescriber's preferences are completely ignored. The biggest dissatisfaction of all among prescribers, however, is the lack or inconsistent supply of physical samples in their hands. These prescribers may not have easy access to the sales representative 106. And even if access were possible, the sales representative 106 may not have a ready supply of physical samples for these prescribers to use. The literature has shown that if a prescriber is dissatisfied with a drug brand due to lack of physical samples, the prescriber will not prescribe that particular drug brand to patients.
When the sales representative 106 leaves drug samples with the prescriber, the prescriber signs an acknowledgment indicating that these drug samples are now in his possession. Beyond that, however, there is no data that tracks whether drug samples actually get prescribed to patients of the prescriber. No additional information is possible beyond the point at which drug samples are given to the prescriber. So even though the pharma 102 has spent a great deal of money on drug samples, it has no means of knowing whether the physical samples were actually prescribed to patients or tossed uselessly into a garbage can. Without a way to track these drug samples, the pharma 102 cannot improve its drug sample distribution. Moreover, without tracking, expired drug samples may be prescribed to patients, diminishing their efficacy. This may add to wrongful impressions by patients regarding the drug's effectiveness and eventually will lead to a lack of acceptance of the drug in the marketplace.
In the commonly assigned application Ser. No. 10/674,904, a drug sample fulfillment platform is disclosed that may be used by prescribers of drugs for the ordering of drug samples. This prior application describes that to place a drug sample order, a prescriber is required to print the order, sign the order, and then fax the order to the drug sample fulfillment vendor. If the order contains drugs from two vendors, then two faxes need to be sent. This process is burdensome on the prescribers, but necessary to ensure that only true prescribers may use the system. Normally, the responsibility of determining whether the prescriber whose name is on the order form is, in fact, the prescriber who is requesting the drug samples, falls on the drug sample fulfillment vendor.
The Prescription Drug Marketing Act (PDMA) and the Code of Federal Regulations, both of the United States, place requirements on drug sample fulfillment vendors to verify the identity of the prescriber and the validity of the shipping address prior to sending the drug samples. This is typically done by maintaining a copy of the prescriber's signature and a file containing address information about the prescriber. Upon receipt of the request for drug samples, i.e., the faxed form containing the prescriber's signature, the information on the request is validated by the fulfillment vendor against the file copy. Assuming the information matches, the fulfillment vendor fills the order and ships the drug samples to the prescriber. In addition, the fulfillment vendor will require verification that the drug sample order was received. One example of verification may be to require the prescriber to sign and return a card that may be included within the package. The card must be signed by the prescriber and returned to the fulfillment vendor as a positive indication that the shipment has been received. If the prescriber refuses to sign and return the card, or the card is otherwise not returned, the fulfillment vendor will generally refuse further orders from that particular prescriber until the reply card is received. Another verification method that the fulfillment vendor may utilize is to refer to the signed receipt from the package carrier that is signed by the package recipient.
As more and more prescribers begin to use communication networks, such as the global TCP/IP network, commonly referred to as the Internet, for continuing medical education, ordering medical supplies, and so on, there is also an increasing demand to enable the ordering of physical drug samples over a communication network to reduce the time between the placement of the order and the receipt of the drug samples. However, the current method of authenticating prescribers is inadequate and stands in the way of fully conducting drug sample ordering over the Internet. To make the process fully online would require a mechanism to identify valid prescribers who can issue valid orders to fulfillment vendors. The process, however, does not remove the obligation of the fulfillment vendor to perform its normal validity checks, since the PDMA requirements will continue.
Accordingly, there is an increasing need to provide a method and system for the online, real-time, authentication of a prescriber, to provide for a more expedient manner of delivering drug samples from the fulfillment vendors to the prescribers. This will not only benefit the prescribers, but will also benefit the pharmaceutical companies because the more of their drug samples that are prescribed, the more readily accepted the drugs will become in the marketplace.
In sum, not only is it expensive and laborious to develop new drugs, but the traditional drug sample distribution process does not allow the pharma 102 to assess the effectiveness of its drug sample fulfillment program further increasing financial risk to the pharma 102. Not all prescribers can be reached by the sales representative 106, hence limiting the distribution of drug samples to patients who may benefit from them. On the other hand, prescribers who do wish to have an opportunity to try the drug samples cannot readily obtain a consistent supply. Thus, there is a need for an architecture for enhancing drug sample fulfillment distribution while avoiding or reducing the foregoing and other problems.